Method for obtaining data that are useful for the diagnosis, prognosis and classification of patients with chronic obstructive pulmonary disease (copd) and/or lung cancer

Abstract

The invention describes a method for obtaining data useful for the diagnosis, prognosis and classification of individuals with chronic obstructive pulmonary disease (COPD) and/or lung cancer, diagnostic kit, device and uses thereof for the diagnosis, prognosis and classification of patients as a) individuals with no COPD or lung cancer, b) individuals with COPD, c) individuals with adenocarcinoma, d) individuals with COPD and adenocarcinoma, or e) individuals with COPD and squamous carcinoma

1 - 4 . (canceled) 
     
     
         5 . A method for determining that an individual has one of the following:
 a) no COPD or lung cancer;   b) COPD;   c) adenocarcinoma,   d) COPD and adenocarcinoma; or   e) COPD and squamous carcinoma; the method comprising:
 i) obtaining an isolated biological sample of the individual; and 
 ii) quantifying the expression level of at least one gene selected from the group consisting of: IGFBP1, MIP1β, CCL-1, MIG, PDGFAA, GDF-15 and EGF. 
   
     
     
         6 . The method according to  claim 5 , further comprising:
 iii) comparing the expression level of at least one gene determined in step (ii) with a reference level.   
     
     
         7 . The method according to  claim 5 , wherein step (ii) also comprises quantifying the expression level of at least one gene selected from the group consisting of: IL-6sR, IL-1a, IL-11, EOTAXIN-2, TNFIR, TNFRII, IGFBP2, and MCP-1. 
     
     
         8 . The method according to  claim 5 , wherein step (ii) is fully or partially automated. 
     
     
         9 . The method according to  claim 5 , wherein the biological sample is bronchoalveolar fluid. 
     
     
         10 . The method according to  claim 5 , wherein the quantitation is performed by immunoassay. 
     
     
         11 . The method according to  claim 10 , wherein the immunoassay is an ELISA. 
     
     
         12 . The method according to  claim 6  further comprising determining that the individual has no COPD or lung cancer, when no expression of genes IGFBP1, MIPβ, CCL-1, MIG and PDGFAA is found. 
     
     
         13 . The method according to  claim 6  further comprising determining that the individual has adenocarcinoma, when an increase in the expression level of genes IL-11 and/or CCL-1 relative to a reference level is found. 
     
     
         14 . The method according to  claim 6  further comprising determining that the individual has COPD when the expression of MIG is found, and no expression of CCL-1 and IGFBP1 is found. 
     
     
         15 . The method according to  claim 6  further comprising determining that the individual has adenocarcinoma when the expression of CCL-1 is found, and when the expression level of MIP1β is found to be lower than 20 pg/mL. 
     
     
         16 . The method according to  claim 6  further comprising determining that the individual has squamous carcinoma when the expression of PDGFAA or MIP1β at any level is found, and no expression of CCL-1 is found. 
     
     
         17 . The method according to  claim 6  further comprising determining that the individual has COPD and adenocarcinoma when the expression of CCL-1 at any level is found, and the expression level of VEGF is found to be lower than 200 pg/mL. 
     
     
         18 . A method according to  claim 6  further comprising determining that the individual has COPD and squamous carcinoma when the expression level of GDF-15 and VEGF is found to be higher than 50 pg/mL and 200 pg/mL, respectively, and no expression of CCL-1 and EGF is found. 
     
     
         19 - 20 . (canceled) 
     
     
         21 . A kit for carrying out the method of  claim 5 , comprising:
 elements necessary to quantify the expression level of at least one gene selected from the group consisting of: IGFBP1, MIP1β, CCL-1, MIG, PDGFAA, GDF-15, VEGF and EGF; and   instructions for use.   
     
     
         22 . The kit according to  claim 21 , further comprising the elements necessary to quantify the expression level of at least one gene selected from the group consisting from: IL-6sR, IL-1a, IL-11, EOTAXIN-2, TNFRI, TNFRII, IGFBP2 and MCP1. 
     
     
         23 . The kit according to  claim 22  comprising the elements necessary to quantify the expression level of CCL-1 and/or IL-11. 
     
     
         24 . The kit according to  claim 21  comprising, anti-CCL-1 and anti-IL-11 antibodies. 
     
     
         25 . The kit according to  claim 21  comprising anti-IGFBP1, anti-MIP-1B, anti-CCL-1, anti-MIG, anti-PDGFAA, anti-GDF-15, anti-VEGF or anti-EGF antibodies. 
     
     
         26 . The kit according to  claim 25  comprising anti-IL-6sR, anti-IL-1a, anti-IL-11, anti-EOTAXIN-2, anti-TNFRI, anti-TNFRII, anti-IGFBP2 and anti-MCP1 antibodies. 
     
     
         27 . (canceled) 
     
     
         28 . A computer readable storage means comprising software instructions that direct a computer to perform the steps of the method according to  claim 5 . 
     
     
         29 . The storage means according to  claim 28 , comprising the antibodies anti-IGFBP1, anti-MIP-1B, anti-CCL-1, anti-MIG, anti-PDGFAA, anti-GDF-15, anti-VEGF or anti-EGF. 
     
     
         30 - 32 . (canceled) 
     
     
         33 . A transmissible signal comprising software instructions that direct a computer to perform the steps of the method according to  claim 5 .